BEUDAMED
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    IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Recall
    Terminated ·Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom·Product code CIN·August 10, 2012

    IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Recall
    Terminated ·Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom·Product code NEO·August 10, 2012

    IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Enforcement
    Class II ·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012

    IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Recall
    Terminated ·Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom·Product code JIT·August 10, 2012

    IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid¿ Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Enforcement
    Class II ·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012

    IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Enforcement
    Class II ·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012

    IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum or plasma on the IDS-iSYS Multi- Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of post menopausal osteoporosis and Pagets disease.

    FDA Enforcement
    Class II ·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012

    IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Enforcement
    Class II ·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012

    IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Recall
    Terminated ·Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom·Product code CIN·August 10, 2012

    IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Assay is intended for the quantitative determination of Osteocalcin in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to assist the clinician. Osteocalcin is an indicator of osteoblastic activity in human serum and plasma and is intended to be used as an aid in the prevention of osteoporosis.

    FDA Enforcement
    Class II ·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012

    IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum or plasma on the IDS-iSYS Multi- Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of post menopausal osteoporosis and Pagets disease.

    FDA Recall
    Terminated ·Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom·Product code CIN·August 10, 2012

    Simplastin HTF Reagents, 20ml HO, ( and 6 ml HO) bioMerieux, Inc., Durham, NC 27704

    FDA Recall
    Terminated ·BIOMERIEUX, INC.·Product code GJS·March 7, 2005

    IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid Osteocalcin Assay is intended for the quantitative determination of Osteocalcin in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to assist the clinician. Osteocalcin is an indicator of osteoblastic activity in human serum and plasma and is intended to be used as an aid in the prevention of osteoporosis.

    FDA Recall
    Terminated ·Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom·Product code NEO·August 10, 2012

    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

    FDA Enforcement
    Class I ·Terminated·Teleflex Medical·March 5, 2014

    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

    FDA Enforcement
    Class I ·Terminated·Teleflex Medical·March 5, 2014

    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

    FDA Enforcement
    Class I ·Terminated·Teleflex Medical·March 5, 2014

    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

    FDA Enforcement
    Class I ·Terminated·Teleflex Medical·March 5, 2014

    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

    FDA Enforcement
    Class I ·Terminated·Teleflex Medical·March 5, 2014

    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

    FDA Enforcement
    Class I ·Terminated·Teleflex Medical·March 5, 2014

    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

    FDA Enforcement
    Class I ·Terminated·Teleflex Medical·March 5, 2014